Dr Reddy's gets two USFDA observations for Srikakulam plant

Dr.Reddy’s on Tuesday said it was issued a Form 483 with 2 observations by US FDA for its active pharmaceutical ingredient manufacturing plant in Srikakulam.

The company said was addressing the observations raised by US FDA without specifying the nature of those observations.

Srikakulam API plant also called CTO-6 was undergoing a US FDA re-audit that began on 27 March. The audit ended Tuesday.

Srikakulam API plant was issued a warning letter from US FDA in November 2015 and has undertaken remediation measures. US FDA in its warning letter reprimanded the plant for non-compliance of data standards in lab tests, unauthorized access, and poor record-keeping practices.

The plant supplies active ingredients for Dr Reddy’s captive consumption as well as for meeting its customer needs. The CTO-6 is the largest API manufacturing plant of the company contributing about 10 percent of sales when Dr Reddy’s received the warning letter.

Dr Reddy's said it collectively spent about USD 35-40 million on remediation work that includes legal and professional charges.

The drugmaker in March received repeat observations from the US FDA on its Duvvada oncology formulation facility in Visakhapatnam.